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Ferumoxytol for Intracranial Atherosclerosis

Phase 1
Waitlist Available
Led By Adam de Havenon, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intracranial atherosclerosis (stenosis ≥50%)
Recent ischemic stroke (less than or equal to 14 days)
Must not have
Documented history of atrial fibrillation
Carotid stenosis greater than 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will use high-resolution MRI to study the correlation between vessel wall enhancement (a marker of inflammation) and stroke risk in patients with cerebrovascular disease.

Who is the study for?
This trial is for adults who've had a recent ischemic stroke (within the last 14 days) and have significant intracranial artery narrowing (stenosis ≥50%). It's not suitable for those under 18, with atrial fibrillation history, severe carotid stenosis (>70%), pregnancy, contrast allergies, serious kidney issues, pacemaker or MRI contraindications, iron sensitivity or high ferritin/transferrin levels.
What is being tested?
The study tests Ferumoxytol Injectable Product as an MRI contrast agent to detect inflammation in brain arteries after a stroke. The goal is to understand if vessel wall enhancement on MRI can predict strokes by showing local inflammation within plaques in the brain's arteries.
What are the potential side effects?
Potential side effects of Ferumoxytol include nausea, dizziness, low blood pressure reactions at injection site like swelling or pain. There may also be risks associated with its use in patients with iron overload conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a significant narrowing in my brain's arteries.
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I had a stroke less than 14 days ago.
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I had a stroke less than 14 days ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a documented history of atrial fibrillation.
Select...
I have a narrowing in my carotid artery of more than 70%.
Select...
I am under 18 years old.
Select...
My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vessel Wall Enhancement with Gadolinium compared to Vessel Wall Enhancement with Ferumoxytol in intracranial atherosclerosis (ICAS) group.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
80 patients with intracranial atherosclerosis

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,139 Previous Clinical Trials
1,697,280 Total Patients Enrolled
20 Trials studying Stroke
3,417 Patients Enrolled for Stroke
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,040,325 Total Patients Enrolled
17 Trials studying Stroke
16,454 Patients Enrolled for Stroke
Adam de Havenon, MDPrincipal InvestigatorYale School of Medicine
2 Previous Clinical Trials
170 Total Patients Enrolled
2 Trials studying Stroke
170 Patients Enrolled for Stroke

Media Library

Ferumoxytol Injectable Product Clinical Trial Eligibility Overview. Trial Name: NCT03084523 — Phase 1
Stroke Research Study Groups: 1
Stroke Clinical Trial 2023: Ferumoxytol Injectable Product Highlights & Side Effects. Trial Name: NCT03084523 — Phase 1
Ferumoxytol Injectable Product 2023 Treatment Timeline for Medical Study. Trial Name: NCT03084523 — Phase 1
~0 spots leftby Dec 2024
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